NCT04352439

Brief Summary

This is a pilot study to determine the safety and efficacy of low dose aspirin for the prevention of venous thromboembolism among women with advanced ovarian cancer receiving neoadjuvant chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

August 8, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2022

Completed
7 months until next milestone

Results Posted

Study results publicly available

September 26, 2022

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

1.6 years

First QC Date

April 13, 2020

Results QC Date

August 9, 2022

Last Update Submit

September 6, 2022

Conditions

Venous ThromboembolismOvarian Cancer

Outcome Measures

Primary Outcomes (3)

  • Number of Participants Experiencing a Venous Thromboembolism

    Up to six months

  • Number of Participants With at Least One Adverse Event

    Adverse events will only include those that are determined to be related to the study drug.

    Up to six months

  • Medication Adherence

    Patient adherence to aspirin as defined by percent of pills used.

    Up to six months

Study Arms (1)

Aspirin

EXPERIMENTAL

Patients with a Khorana risk score of 1 receive 81 mg aspirin daily while receiving neoadjuvant chemotherapy for ovarian cancer.

Drug: Aspirin

Interventions

AspirinDRUG

81 mg aspirin daily

Aspirin

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Khorana score = 1
  • Over age 18
  • English-speaking female patients
  • Able to consent
  • Receiving neoadjuvant chemotherapy Cancer of primary ovarian, fallopian tube, mullerian, or peritoneal origin

You may not qualify if:

  • Allergy or intolerance to study medication
  • Indication for a non-aspirin form of antiplatelet (i.e. cardiac stent)
  • Already on alternative form of anticoagulation
  • Active bleeding
  • High risk for active bleeding (i.e. recent intracranial bleed or gastrointestinal bleed, known brain metastases)
  • Thrombocytopenia (platelets \<50,000)
  • Unable to complete medication adherence diary
  • Unable to take oral medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sarasota Memorial HealthCare System

Sarasota, Florida, 34329, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

  • Salinaro JR, McQuillen K, Stemple M, Boccaccio R, Ehrisman J, Lorenzo AM, Havrilesky L, Secord AA, Galvan Turner V, Moore KN, Davidson B. Incidence of venous thromboembolism among patients receiving neoadjuvant chemotherapy for advanced epithelial ovarian cancer. Int J Gynecol Cancer. 2020 Apr;30(4):491-497. doi: 10.1136/ijgc-2019-000980. Epub 2020 Feb 12.

    PMID: 32054646BACKGROUND

  • Faour M, Piuzzi NS, Brigati DP, Klika AK, Mont MA, Barsoum WK, Higuera CA. Low-Dose Aspirin Is Safe and Effective for Venous Thromboembolism Prophylaxis Following Total Knee Arthroplasty. J Arthroplasty. 2018 Jul;33(7S):S131-S135. doi: 10.1016/j.arth.2018.03.001. Epub 2018 Mar 8.

    PMID: 29656974BACKGROUND

  • Key NS, Khorana AA, Kuderer NM, Bohlke K, Lee AYY, Arcelus JI, Wong SL, Balaban EP, Flowers CR, Francis CW, Gates LE, Kakkar AK, Levine MN, Liebman HA, Tempero MA, Lyman GH, Falanga A. Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: ASCO Clinical Practice Guideline Update. J Clin Oncol. 2020 Feb 10;38(5):496-520. doi: 10.1200/JCO.19.01461. Epub 2019 Aug 5.

    PMID: 31381464BACKGROUND

MeSH Terms

Conditions

Venous ThromboembolismOvarian Neoplasms

Interventions

Aspirin

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr. Brittany Davidson
Organization
Duke University
brittany.davidson@duke.edu
+1 919 684 0188

Study Officials

  • Brittany Davidson, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 20, 2020

Study Start

August 8, 2020

Primary Completion

March 2, 2022

Study Completion

March 2, 2022

Last Updated

September 26, 2022

Results First Posted

September 26, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)